Nivolumab for Tumor, Colorectal

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tumor, Colorectal+3 More
Nivolumab - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is looking at a new combination treatment for people with colon or rectal cancer that has spread and who have already been treated.

Eligible Conditions
  • Tumor, Colorectal
  • Neoplasms, Colorectal
  • Colorectal Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Tumor, Colorectal

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: Up to 100 months

Approximately 100 months
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)
Approximately 24 months
Disease control rate (DCR)
Duration of response (DOR)
Objective response rate (ORR) (Part 1A and Part 1)
Objective response rate (ORR) by investigator (Part 1B and Part 2)
Neoplasms
Time to response (TTR)
Approximately 40 months
Overall survival (OS)
Up to 100 months
Incidence of Deaths
Up to 23 months
Incidence of dose limiting toxicity (DLTs)
Up to 24 months
Best overall response (BOR)
Up to 77 months
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests

Trial Safety

Safety Progress

1 of 3

Other trials for Tumor, Colorectal

Side Effects for

NIVOLUMAB 3 mg/kg
38%Fatigue
29%Nausea
28%Decreased appetite
25%Cough
25%Diarrhoea
24%Dyspnoea
20%Vomiting
19%Constipation
14%Anaemia
14%Weight decreased
13%Malignant neoplasm progression
13%Aspartate aminotransferase increased
13%Arthralgia
13%Back pain
13%Pruritus
12%Pyrexia
12%Rash
11%Oedema peripheral
10%Dizziness
10%Myalgia
10%Productive cough
10%Abdominal pain
9%Non-cardiac chest pain
9%Alanine aminotransferase increased
9%Hypoalbuminaemia
9%Hyponatraemia
9%Headache
8%Asthenia
7%Hypothyroidism
7%Upper respiratory tract infection
7%Hypokalaemia
7%Musculoskeletal pain
6%Insomnia
6%Chills
6%Nasopharyngitis
6%Lymphocyte count decreased
6%Blood alkaline phosphatase increased
6%Hyperglycaemia
6%Musculoskeletal chest pain
6%Pain in extremity
6%Haemoptysis
6%Dry skin
6%Dyspepsia
5%Dysgeusia
5%Hypomagnesaemia
5%Rash maculo-papular
4%Pneumonia
4%Blood creatinine increased
4%Muscular weakness
3%Stomatitis
3%Chest pain
3%Hypophosphataemia
3%Dysphonia
3%Pneumonitis
2%Pleural effusion
2%Pulmonary embolism
2%Mucosal inflammation
2%Peripheral sensory neuropathy
2%Alopecia
2%Lung infection
2%Pericardial effusion malignant
2%Epistaxis
1%Acute coronary syndrome
1%Adrenal insufficiency
1%General physical health deterioration
1%Hypersensitivity
1%Urinary tract infection
1%Hip fracture
1%Infusion related reaction
1%Gamma-glutamyltransferase increased
1%Dehydration
1%Hypercalcaemia
1%Pathological fracture
1%Malignant pleural effusion
1%Cancer pain
1%Lung neoplasm malignant
1%Cerebrovascular accident
1%Confusional state
1%Metastases to spine
1%Syncope
1%Chronic obstructive pulmonary disease
1%Renal failure
1%Pneumothorax
1%Respiratory failure
1%Pulmonary haemorrhage
1%Deep vein thrombosis
1%Lacrimation increased
1%Neutropenia
1%Thrombocytopenia
1%Platelet count decreased
1%Neutrophil count decreased
1%Colitis
1%Cholecystitis acute
1%Sepsis
1%Lower respiratory tract infection
1%Metastases to central nervous system
1%Tumour pain
1%Seizure
1%White blood cell count decreased
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT02041533) in the NIVOLUMAB 3 mg/kg ARM group. Side effects include: Fatigue with 38%, Nausea with 29%, Decreased appetite with 28%, Cough with 25%, Diarrhoea with 25%.

Trial Design

6 Treatment Groups

Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinib
1 of 6
Part 2 Cohort 5 (3L): Regorafenib
1 of 6
Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinib
1 of 6
Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinib
1 of 6
Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinib
1 of 6
Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinib
1 of 6
Experimental Treatment

232 Total Participants · 6 Treatment Groups

Primary Treatment: Nivolumab · No Placebo Group · Phase 1 & 2

Part 1A Cohort 2 2nd Line (2L): nivolumab + ipilimumab + trametinibExperimental Group · 3 Interventions: Trametinib, Ipilimumab, Nivolumab · Intervention Types: Drug, Biological, Biological
Part 2 Cohort 5 (3L): Regorafenib
Drug
Experimental Group · 1 Intervention: Regorafenib · Intervention Types: Drug
Part 1 Cohort 1 3rd Line (3L): nivolumab + trametinibExperimental Group · 2 Interventions: Trametinib, Nivolumab · Intervention Types: Drug, Biological
Part 1A Cohort 3 (2L): nivolumab + ipilimumab + trametinibExperimental Group · 3 Interventions: Trametinib, Ipilimumab, Nivolumab · Intervention Types: Drug, Biological, Biological
Part 2 Cohort 4 (3L): nivolumab + ipilimumab + trametinibExperimental Group · 3 Interventions: Trametinib, Ipilimumab, Nivolumab · Intervention Types: Drug, Biological, Biological
Part 1B Cohort 6 (2L): nivolumab + ipilimumab + trametinibExperimental Group · 3 Interventions: Trametinib, Ipilimumab, Nivolumab · Intervention Types: Drug, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
FDA approved
Regorafenib
FDA approved
Ipilimumab
FDA approved
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 100 months

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,481 Previous Clinical Trials
3,919,640 Total Patients Enrolled
NovartisIndustry Sponsor
1,579 Previous Clinical Trials
2,697,636 Total Patients Enrolled
1 Trials studying Tumor, Colorectal
49 Patients Enrolled for Tumor, Colorectal

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Microsatellite status should be performed per local standard of practice, immunohistochemistry (IHC) and/or PCR
You have previously been treated for metastatic colorectal cancer with a curative intent and have a histologically or cytologically confirmed adenocarcinoma histology.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.